Kornimate/medical-research-clean huggingface dataset:
genetic susceptibility factor as a predictor of type 2 diabetes remission and weight loss after bariatric surgery

Conditions: Case-control Study

Summary: obesity is directly related to an increased risk of diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, and overall mortality. weight loss is effective in decreasing these risks and to reduce disease severity. bariatric surgery is an effective therapy for sustained weight loss and type 2 diabetes (t2d) remission in most of the morbidly obese patients. but there is also a significant number of individuals with an inappropriate response to bariatric surgery. two recent retrospective studies assessed the role of genetic load as a predictor of this response, but the results are still unelucidated. the aim of this study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after bariatric surgery in terms of weight loss and t2d remission.

a retrospective case-control study of 100 women who underwent bariatric surgery (roux-en-y laparoscopic gastric bypass): 50 pacients who were diabetic before surgery: 15 cases with less than 40% of the excess weight loss (ewl) and 35 cases with more than 75% ewl, matched with 50 non diabetic controles: 15 patients with less than 40%ewl and 35 with more than 75%ewl after one year. all individuals were analyzed with a genetic score from nutri incode. the predictive ability was analyzed by discrimination (area under the roc curve), sensitivity and specificity and a score was calculated.

Eligibility criteria:
inclusion criteria: * women who underwent a gastric bypass with a minimum of 1 year follow-up, * aged between 18 and 60 years, * stable weight in the previous 6 months, * have signed the informed consent. exclusion criteria: * male, * with mobility problems that constrain a marked inactivity, * with pathology that limits the practice of within normal limits (chronic obstructive pulmonary cardiac cerebral vascular-disease, illness, accident sequel, etc ), * undergoing different surgical techniques to gastric bypass, * with severe psychiatric disorders or eating disorder.
should i continue taking my acid reflux medication? development and pilot testing of a patient decision aid

Conditions: Proton Pump Inhibitors; Gastroesophageal Reflux Disease

Summary: background: proton pump inhibitors (ppis) treat problems such as gastroesophageal reflux disease (gerd). in many patients with mild or moderate gerd, ppis should be used for 1-2 months but are often continued longer unnecessarily. this is a problem because ppis may cause harm when used long-term. ppi use is associated with severe c. difficile infections, fractures and pneumonia. canada's public drug programs spent $247 million on ppis in 2012 (not including quebec or pei). due to concerns with long-term ppi use, patients may face the decision to continue their ppi, use a lower dose or stop and use on-demand (only when symptoms return). this decision should be made collaboratively between patients and clinicians, though patients tend to have a poor understanding of when reducing a drug is appropriate. using a lower dose or using on-demand may be viewed as difficult because of the chance of symptoms returning. patient decision aids (pdas) inform patients on benefits and risks of treatment options and improve ability to make informed decisions and clarify values. objectives: develop a pda to help patients with the decision to continue ppi or stop and use on-demand/use a lower dose. evaluate whether: 1) the pda changes patient preference to continue or stop and use on-demand/use a lower dose of ppi 2) the pda improves patient knowledge and realistic expectations 3) patients and pharmacists feel they made a shared decision 4) there is a change in ppi prescribing 8 weeks post-pda and 5) patients' choices match up with their values. methodology: the pda will be developed by a team of doctors, pharmacists and patients. it will be delivered during a visit with a pharmacist. patients (n=54) will indicate which choice they prefer (continue ppi/stop or use lower dose) before and after going through the pda. we will use mcnemar's test to compare the number of patients preferring to continue their ppi before and after. we will evaluate whether there is a difference in knowledge test scores and expectations test scores before and after the pda. after the pda, we will ask patients and pharmacists to rate the extent to which shared decision making occurred and measure the agreement. values/choice congruence will be evaluated using logistic regression. eight weeks after patients have received the pda, we will look at whether there is any reduction in ppi use.


Eligibility criteria:
inclusion criteria: * taking ppi for greater than or equal to 4 weeks, no current symptoms, taking ppi for mild to moderate upper gi symptoms (mild to moderate gastroesophageal reflux disease, grade a/b esophagitis) exclusion criteria: * severe esophagitis (grade c/d), severe gerd or upper gi symptoms, currently experiencing upper gi symptoms, taking ppi for gastroprotection due to nsaid therapy (at moderate or high risk of gi bleed), history of barrett's esophagus, history of bleeding peptic ulcer, taking ppi for treatment of current ulcer not healed

Keywords: patient decision aid
live microbials to boost anti-severe acute respiratory syndrome coronavirus-2 (sars-cov-2) immunity clinical trial

Conditions: Covid19

Summary: this pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with sars-cov-2.

this pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses (a standard dose and a high dose) of a combination of live microbials (probiotics), currently marketed in food (including products labeled as dietary supplements), given daily for 21 days to boost the immunity of unvaccinated, generally healthy persons ages 18-60 with prior confirmed sars-cov-2 infection. data collected will include demographics, comorbidities, medications, information about prior sars-cov-2 infection, and self-reported symptoms and adverse events (aes). biospecimens (saliva, nasal wash, blood, and stool) will be collected at baseline and days 21 and 42 for analysis.

Eligibility criteria:
inclusion criteria: * healthy adults (any gender, ages 18 to 60 years old) in good general health, based on medical history * sars-cov-2 infection \>4 months prior confirmed by a positive polymerase chain reaction (pcr) or antigen test * body mass index (bmi) of 18.5-39.9 kg/m2 * agreement to comply with the protocol and study restrictions * access to internet in addition to willingness and ability to use web-based questionnaires * available for all study visits * english-speaking exclusion criteria: * recent infection with coronavirus disease-2019 (covid-19) (newly positive pcr or antigen test within prior 4 months) * prior receipt of antibody therapies (convalescent or monoclonal) towards covid-19 * prior receipt of vaccines against covid-19 * prior or current participation in a clinical trial of vaccines against covid-19 * scheduled to receive a vaccine against covid-19 in the following month * regular use of any live microbial (probiotic) supplements * any acute or chronic respiratory tract disease besides mild to moderate asthma * any diagnosed immunodeficiency * current use of immunosuppressive drugs * any diagnosis of chronic gut disease, such as inflammatory bowel disease or irritable bowel syndrome * pregnancy or breastfeeding * recent use of antibiotics * current addiction to alcohol, drugs, or medications

Keywords: probiotics
safety and efficacy of an early rehabilitation program in surgical intensive care unit

Conditions: ICU-acquired Weakness

Summary: the purpose of this study is to determine whether an early rehabilitation program in surgical intensive care unit is safe and effective in preventing critical care illness and intensive care unit acquired weakness.

due to the complications like intensive care unit-acquired weakness, critical illness polyneuropathy and neuropsychiatric disease of critical care, many organizations focus on rehabilitation in critically ill patients' management. despite the good outcomes from papers, there are debatable issues of method, safety and efficacy of rehabilitation. the investigators developed an early rehabilitation program (erp) in our surgical icu management and assessed safety and efficacy of it. the erp started in november 2014 in our 14-bed surgical icu in asan medical center. the investigators focused on early and 5-step rehabilitation program for patients who were admitted to sicu for at least 3 days. the investigators enrolled 69 patients (pre-erp group) for 6 months before november 2014 and 62 patients (post-erp group) for 6 months 1 year after the erp started. the main measures were safety issues, delirium days, 28-d ventilator free-days, 28-d icu free-days, hospital length of stay (los), icu mortality, in-hospital mortality and 1 year mortality.

Eligibility criteria:
inclusion criteria: * patients who were admitted in sicu for at least 3 days exclusion criteria: * readmission to sicu within current hospitalization open abdomen wound patients major bone fracture patients brain death patients active bleeding patients increased intra-cranial pressure patients paraplegic patients patients or their guardians did not agree with the erp doctor's decision (deconditioning patients, procedure)

Keywords: early rehabilitation early mobilization surgical intensive care unit
telemedicine intervention to improve cognitive function

Conditions: Parkinson's Disease

Summary: this project is investigating whether a home-based exercise program will reduce cognitive decline in patients with parkinson's disease.

background/rationale: progressive cognitive impairment leading to dementia is an important component of parkinson's disease (pd), contributing to significant levels of disability. the number of veterans who will develop pd and, in turn, the number of veterans with pd who develop dementia is likely to increase substantially. given the profound negative health and social consequences associated with the development of dementia, it is critical to identify interventions that effectively slow the decline of cognitive function to prolong the time to onset of dementia. based on the results of prior studies, physical activity is one of the few nonpharmacological interventions that holds promise in slowing cognitive decline. objective: the investigators hypothesize that a home-based physical activity intervention to promote walking will reduce cognitive decline in veterans with mild cognitive impairment in pd (pd-mci). methods: the proposed study is a randomized, controlled trial of a home-based walking intervention, evaluating effects on cognitive function. community-dwelling veterans with pd-mci will be randomized to a walking intervention or a health education control intervention. subjects will be male and female veterans with a physician diagnosis of idiopathic, typical pd, with at least 2 of 3 cardinal signs of pd, response to dopaminergic medication, and mci. the interventions will last 18 months.

Eligibility criteria:
inclusion criteria: * physician diagnosis of idiopathic, typical parkinson's disease (pd) * at least 2 of 3 cardinal signs of pd * response to dopaminergic medication * mild cognitive impairment exclusion criteria: * angina pectoris * history of myocardial infarction within 6 months * history of ventricular dysrhythmia requiring current therapy

Keywords: parkinson's disease exercise therapy mild cognitive impairment
a multicenter, randomized, double-blind, placebo controlled, clinical trial to evaluate the safety, tolerability and preliminary effectiveness of 2 doses of intradiscal rhgdf-5 (single administration) for the treatment of early stage lumbar disc degeneration

Conditions: Degenerative Disc Disease

Summary: study to show the safety and tolerability of intradiscal rhgdf-5 in subjects with early lumbar disc degeneration


Eligibility criteria:
inclusion criteria: 1. persistent low back pain with at least 3 months of non-surgical therapy at one suspected symptomatic lumbar level (l3/l4 to l5/s1) as confirmed using a standardized provocative discography protocol. the required discography protocol will be provided by the sponsor. subjects with multilevel disease must have a provocative discogram confirming that only 1 level is symptomatic at least 2 weeks prior to administration. historical provocative discograms may be used for screening purposes, with an expiry of 12 calendar months from the date performed. if the study treatment is not performed within those 12 calendar months, a new discogram will be required. 2. oswestry disability index (odi) for low back pain of 30 or greater 3. low back pain score greater than or equal to 4 cm as measured by visual analog scale (vas) at visit 1 baseline exclusion criteria: 1. persons unable to have a discogram, ct, or mri 2. abnormal neurological exam at baseline (e.g., chronic radiculopathy) 3. active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee) 4. extravasation of contrast agent during the discogram, into the epidural space (does not include leakage of contrast agent along the needle track or leakage to the outer annular ring at the posterior longitudinal ligament vicinity) 5. suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments
multi-center registry for me/cfs

Conditions: ME/CFS; CFS/ME; ME/CFS Following EBV-associated Infectious Mononucleosis; ME/CFS Following COVID-19

Summary: the me/cfs study (mecfs-r) aims to create a large-scale registry that provides data on epidemiology, phenotypes, and disease trajectories of and health care for me/cfs at any age in germany, which can be used for future clinical trials.

me/cfs (icd-10 g93.3) is a multisystem chronic disease that can lead to severe disability. pre-pandemic prevalence was estimated at approximately 0.3% worldwide, and increasing prevalence is observed due to me/cfs in the context of long-term sequelae of coronavirus diseases 2019 (covid-19). in germany, the number of affected people in germany was estimated as approximately 350.000-400.000 in 2018/2019 and almost 500.000 in 2021. me/cfs can manifest at any age, with peak prevalence in adolescents and young adults. common triggers include covid, influenza, and epstein-barr virus-associated infectious mononucleosis (ebv-im). non-infectious triggers are known as well. autoimmunity and dysfunction of the autonomic nervous system (ans) were suggested as possible pathomechanisms. core symptoms include fatigue, post-exertional malaise (pem), and unrefreshing sleep. additional symptoms comprise cognitive deficits ("brain fog"), orthostatic intolerance, neuroendocrine, and immunological symptoms. me/cfs is diagnosed according to clinical criteria (mostly criteria by the institute of medicine (iom) or canadian consensus criteria) and by appropriate differential diagnostics to exclude other disorders with similar symptoms. so far, no biomarker or specific therapy is available. therapeutic approaches are holistic and aim at the palliation of symptoms as well as psychosocial support. self-management with pacing is recommended. knowledge of me/cfs among healthcare providers is still scarce, and many patients do not receive adequate care. with this web-based, german-wide registry, the investigators aim at deep phenotyping of the disease, identification of subtypes and risk factors, describing trajectories of the disease and patient journeys, and providing clinical data for future clinical trials. patients are also invited to contribute biosamples for future translational research.

Eligibility criteria:
inclusion criteria: * me/cfs diagnosis (icd-10 g93.3) based on internationally established criteria * informed consent by patients and/or guardian(s) exclusion criteria: * no me/cfs (icd-10 g93.3) * no informed consent

Keywords: me/cfs cfs/me sars-cov-2 covid-10 post-covid-19 condition chronic fatigue syndrome myalgic encephalomyelitis epstein-barr virus ebv
metformin in high responder polycystic ovary syndrome (pcos) patients undergoing ivf cycles

Conditions: Infertility; Polycystic Ovary Syndrome (PCOS)

Summary: the use of metformin pre-treatment and co-administration was recently proposed in infertile women affected by polycystic ovary syndrome (pcos) treated with gonadotropins. data from meta-analyses showed that metformin administration significantly reduced the stimulation length and the total dose of gonadotropins used in pcos women undergoing gonadotropins stimulation for non in-vitro fertilization (ivf) cycles. on the other hand, in ivf cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation syndrome (ohss) rate in infertile patients with pcos treated with gonadotropins. the metformin regulating effect on the ovarian response was also observed in a randomized controlled trial (rct) on young non-obese insulin-resistant women with pcos receiving gonadotropins for mono-ovulation induction. in particular, metformin increased the mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used, while it reduced the number of dominant follicles and the estradiol (e2) levels. the aim of the present study was to evaluate the effect of metformin administration in high responder pcos patients undergoing gonadotropins ovarian stimulation for ivf cycles.

infertile young non-obese insulin-resistant patients with pcos who had a background of the first ivf treatment cycle cancelled because of high risk for ohss will be enrolled and randomized in two treatment arms. in their second ivf attempt, the experimental group will receive metformin (500 mg, 3 times daily) pre-treatment for two weeks and co-administration during gonadotropins ovarian stimulation; the control group will be treated with placebo (2 cps daily) pre-treatment and co-administration by using the same schedule of the experimental group. in all patients, ovarian stimulation will be carried out with a personalized step-down gonadotropin in association with a minidose flare-up gnrh agonist protocol.

Eligibility criteria:
inclusion criteria: * history of one previous cancelled cycle for high-risk of ohss, or history of moderate/severe ohss during their previous ivf cycle * infertility * polycystic ovary syndrome (pcos) * insulin resistance * hyperandrogenism exclusion criteria: * bmi\>30 kg/m2 * age \>35 years * fsh\>9ui/l

Keywords: pcos polycystic ovary syndrome cancelled cycles ohss infertility
a prospective study using suprasdrm® in promoting healing and reducing the time to grafting of full-thickness wounds

Conditions: Surgical Wound; Burns; Trauma Injury

Summary: this is a prospective, randomized, controlled, multi-center clinical study comparing suprasdrm® to standard of care wound dressing, btm, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.

twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. an area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. the study site will be randomized to receive either suprasdrm® or the soc wound dressing, novosorb® btm.

Eligibility criteria:
inclusion criteria: * patient age ≥18 years and ≤85 years * full-thickness traumatic injury, surgical wound, or excised full-thickness burn (e.g., friction, contact, flame, scalding etiology), where immediate grafting is not deemed suitable by the treating surgeon * wound size ≥ 5cm2 not immediately suitable for graft application * subject or legally authorized representative is able and willing to sign informed consent exclusion criteria: * study wound may not include areas of the face, and neck and genitalia. * wound with metal hardware exposure * pressure sores * wounds with residual malignancy * wound infection at the time of planned wound dressing application * wound that is a part of an active treatment arm of an interventional study (within 90 days of screening visit) * pregnancy/lactation * subjects who are unable to follow the protocol or who are likely to be non-compliant * subjects with uncontrolled diabetes (defined by hgb a1c \>10) * subjects who are receiving systemic steroids or immune suppressive treatment * subject with a known allergy to polylactide, polycaprolactone, polyvinyl alcohol, trimethylene carbonate or resorbable suture materials. * prisoners
clinical investigation on the effects of a vegetable juice treatment

Conditions: Vegetables; Cardiovascular Disease; Blood Pressure

Summary: the purpose of the investigators study is to investigate the impact of a commercial vegetable juice on dietary vegetable intake and select cardiovascular risk factors in a generally healthy population. the study was a 12 week study with 3 groups who received 0, 8 or 16 fluid ounces daily of vegetable juice, along with education on the dash (dietary approaches to stop hypertension) diet. all participants came in for 3 study visits at 0, 6 and 12 weeks into the study.


Eligibility criteria:
\*\*\*inclusion criteria\*\*\* * age 40 to 65 yrs * subject's body mass index is between 18.5 - 34.9 kg/m2 * subject is willing and able to comply with the study protocols * subject is willing to consume a vegetable-based beverage daily for three months \*\*\*exclusion criteria\*\*\* * physical signs of health impairment * uncontrolled diabetes or hypertension * pregnant or lactating * active tuberculosis or lung disease (i.e. copd) * renal or liver disease * heart disease, which includes cardiovascular events and stroke * cushing's syndrome * exercise trained individuals * history of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year * anxiety medications * use of maoi inhibitors within the last 1 year (e.g., phenelzine (nardil), tranylcypromine (parnate), etc.) * quality of life score of 21 or above * routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, cox-2 inhibitors, antihistamines, corticosteroids, erectile dysfunction drugs * asthma (can be worsened by mild to moderate food allergies) * indications of substance or alcohol abuse within the last 3 years * the volunteer is undergoing nicotine cessation therapy * laboratory values outside the reference range if determined to be clinically significant by dr. m. eric gershwin * individuals with known salt-sensitive hypertension * history of stage 1 high blood pressure defined as systolic \> 140 and diastolic \> 90, with or without use of htn medications * multi-vitamin use other than a one-a-day essential * use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils and unwilling to discontinue use while participating in the study * allergies to vegetables

Keywords: vegetable juice cardiovascular blood pressure